Effect of a Ph Lowering Wound Therapeutic on MMP Levels and Bacterial Biofilm Colonization of Chronic Nonhealing Wounds

Introduction: Patients with chronic lower extremity wounds are reported to have inflammation associated with biofilm bacterial colonization of the wound bed. A novel therapy, Theraworx (TWX), has been developed that reduces the pH of skin and wound tissue, increasing resistance to bacterial colonization. In this study, we have applied TWX to chronic non-healing leg ulcers and measured key wound parameters before and after four weeks of TWX therapy.

Methods: In 18 patients with chronic ulcers, baseline patient and wound characteristics were obtained and wound fluid and tissue samples were obtained for MMP and bacterial biofilm analysis. The patients were treated for four weeks with standard treatment plus application of TWX to the wound and peri-wound areas. At weekly visits, wound fluid and tissue samples were obtained for MMP and bacterial analysis.

Results: Twelve of the 18 patients healed >30% over the four-week treatment phase. The mean wound size decreased significantly from 31.0 ± 28.1 cm² at baseline to 20.7 ± 20.9 cm² after four weeks (p=.01). At baseline, the mean MMP-9 level was 9.6 ± 9.1 RFU/min. After four weeks of TWX treatment, this level decreased to 5.8 ± 4.6 RFU/min (p=.073). At baseline, 14 of 18 patients had detectable levels of biofilm activity with a mean of 115,429 CFU/ml of homogenate. After TWX treatment, 13 of 18 had a reduction in the number of CFU/ml of homogenate and nine had <2 CFU/ml. At four weeks, mean biofilm activity had reduced to 4,022 CFU/ml of homogenate (p=.17).

Conclusions: Treatment of chronic non-healing wounds with TWX therapy resulted in reduction of biofilm wound involvement and MMP-9 levels. Wound size decreased significantly, with most achieving >30% closure during the four-week treatment phase. Study in additional patients will further define the beneficial effects of TWX on chronic non-healing wounds.